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Study of Remternetug for Prevention of Disease Progression in People at Risk for or With Early Onset Inherited Alzheimer's Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Dominantly Inherited Alzheimer's Disease (DIAD), a rare genetic form of Alzheimer's Disease that occurs early in life due to specific genetic mutations. The study will test a new medication called remternetug (also known as LY3372993) against placebo in people who carry these genetic mutations but have not yet developed symptoms. Another substance called Pittsburgh compound B will be used for brain imaging during the study.

The main purpose is to determine if the treatment can prevent or slow down the buildup of harmful proteins in the brain before memory and thinking problems begin. The study is divided into two stages and will use various methods to measure changes in the brain, including special brain scans and tests of spinal fluid.

Participants will receive either remternetug as an injection under the skin or a matching placebo for up to 108 weeks. Throughout the study, participants will undergo various tests to monitor their brain health and check for any changes. The study will also track the safety of the treatment by monitoring for side effects and performing regular health checks.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    You will undergo initial assessment to confirm normal cognitive status using Clinical Dementia Rating Scale

    Your genetic status related to Alzheimer's disease mutations will be verified

    Basic health evaluations including vision and hearing tests will be performed

  2. Step 2

    Baseline measurements

    Brain imaging using PET scan will be performed to measure amyloid levels

    Collection of spinal fluid sample through lumbar puncture to measure various biomarkers

    Initial cognitive testing will be completed to establish baseline measurements

  3. Step 3

    Treatment phase

    You will receive either remternetug (study medication) or placebo through subcutaneous injection

    Regular brain scans using PiB PET will track changes in amyloid levels

    Additional spinal fluid samples will be collected to monitor treatment effects

    Brain structure will be monitored through MRI scans

  4. Step 4

    Monitoring

    Regular cognitive assessments using memory and thinking tests

    Blood tests and health checks will be performed

    Side effects will be monitored throughout the study

    Your study partner will provide information about your daily functioning

  5. Step 5

    Study completion

    Final brain imaging and spinal fluid collection

    Complete set of cognitive tests

    Final health assessment

    The study will continue until 2034

Who can join the trial?

15 criteria

  • Must be at least 18 years old
  • Must provide written informed consent signed by both participant and study partner
  • Must be a carrier of a specific genetic mutation (in APP, PSEN1, or PSEN2 genes) or be at risk of inheriting such mutation from family
  • Must be between 11 to 25 years before the expected age when cognitive symptoms typically begin
  • Must have normal cognitive function (no memory or thinking problems)
  • Must be fluent in languages approved for the study
  • Must have good vision and hearing to complete all study tests
  • Must agree not to donate blood during the study and for a period after the last dose
  • Must have a study partner who can provide accurate information about the participant's mental abilities
  • Must be on stable doses of any current medications for at least 30 days before starting the study
  • For those who can become pregnant:
    • Must have a negative pregnancy test
    • Must not try to become pregnant during the study
    • Must not breastfeed during the study
    • Must use effective birth control methods during the study
    • Must be willing to complete all study tests and procedures

Who cannot join the trial?

15 criteria

  • Age under 18 or over 75 years old
  • Presence of any medical condition that could interfere with the study procedures or participant safety
  • Current or recent participation in other clinical trials (within last 30 days)
  • Known allergies to the study medication or similar compounds
  • Severe psychiatric disorders or conditions affecting cognitive function
  • History of significant heart, liver, or kidney disease
  • Pregnancy, planning to become pregnant, or breastfeeding
  • Use of prohibited medications that might interact with the study drug
  • Inability to comply with study procedures or follow-up visits
  • History of substance abuse within the past 2 years
  • Significant abnormalities in laboratory tests, including blood and heart tests
  • Presence of other neurological conditions that could affect brain function
  • History of bleeding disorders or current use of blood thinners
  • Inability to provide informed consent
  • Major surgery planned during the study period
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Investigated drugs

  • Remternetug

    is an investigational drug being tested to see if it can prevent or slow the buildup of amyloid‑beta plaques in the brain of people who carry genetic mutations that cause dominantly inherited Alzheimer’s disease. In the trial it is given by a subcutaneous injection, and researchers are looking to see whether it can protect the brain and delay disease progression compared with a placebo.

  • PiB

    is a special imaging agent used in the study to measure the amount of amyloid‑beta already present in participants’ brains. It is administered through an intravenous injection during a PET scan, allowing doctors to see and track plaque accumulation over time. This helps the trial team evaluate how well the test drug works by comparing changes in amyloid levels before and after treatment.

What is already known about the treatment

  • LY3372993

    This investigational drug is given as a subcutaneous injection of a clear solution. It is still in clinical trials and has not yet been approved for any medical use. The drug is being tested to prevent or slow the buildup of amyloid‑beta in people with dominantly inherited Alzheimer’s disease. It works by attaching to amyloid‑beta proteins, helping the body clear them, and is classified as an anti‑amyloid monoclonal antibody.

  • PiB

    PiB is administered as an intravenous bolus injection of a radioactive solution. It is a research‑only compound and is not used as a treatment in regular medical practice. The tracer is used to picture amyloid plaques in the brain of patients with Alzheimer’s disease, especially in studies of dominantly inherited forms. It binds to amyloid plaques and emits a signal that can be seen on PET scans, and it is classified as a PET imaging amyloid tracer.

Investigated diseases

Dominantly Inherited Alzheimer's Disease (DIAD) - A rare, genetically determined form of Alzheimer's disease that is passed down through families in an autosomal dominant pattern. This condition typically causes symptoms much earlier than the common form of Alzheimer's disease, often beginning in a person's 30s or 40s. The disease progresses with the accumulation of abnormal proteins (beta-amyloid and tau) in the brain, leading to gradual changes in memory and thinking abilities. DIAD follows a predictable course in affected families, with symptoms typically appearing at about the same age in each generation. The condition affects multiple generations within a family, with each child of an affected parent having a 50% chance of inheriting the disease-causing mutation.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-517187-36-01Protocol codeDIAN-TU-002Estimated enrolment301 patientsSponsorWashington University School Of Medicine

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